This report contains the observations of 9 women who received omeprazo
le for severe reflux disease during different stages of pregnancy. Fou
r patients took omeprazole at the time of conception, and 3 of these p
atients continued omeprazole therapy without interruption until delive
ry. One patient discontinued therapy in the 8th week of pregnancy but
had to take the drug again from the 28th week to delivery. The other 5
patients started therapy in weeks 24, 30, 33, 34 and 36 of pregnancy
because of bleeding in 2 patients and unbearable Hz receptor refractor
y reflux symptoms in the other 3 patients. All patients were carefully
monitored. In all cases omeprazole was well tolerated. No severe side
effects were observed in any of the mothers or their newborns. No mal
functions or malformations were observed in the newborns. Follow-up of
the children between 2 and 12 years showed normal development in all
children. These data together with the data on 8 such pregnancies publ
ished by other authors suggest that omeprazole is safe when given duri
ng pregnancy at whatever phase.